| Summary: | This document, which was prepared with the assistance of the American Blood Bank Association and validated by PAHO/WHO's ad hoc Advisory Group for Blood Banks, is intended to provide blood bank managers with quality assurance standards for their units and blood products. The document, which begins by defining the responsibilities of blood bank managers, establishes norms for maintaining a quality assurance system and for the control of (a) documents, information, and registries; (b) the acquisition of goods and services; (c) procedures, including the processing of autologous blood products; (d) product storage, distribution, transportation, labeling, measurement, and follow-up; (e) the inspection and testing of products and of equipment used to inspect, measure, and test; (f) product inspection status; (g) unsatisfactory products and services, and (h) design of new blood products. In the chapter on process control, which is the longest and most technical, the following are discussed: (a) use of informatics programs; (b) qualifications for donors of allogeneic products; (c) blood collection and storage (d) preparation of blood products; (e) compatibility tests and tests to be performed on donors' blood; (f) labeling, emission, and reemission of products; (g) selection of products for transfusion; (h) general conditions for transfusion; (i) irradiation of blood and blood components; (j) procedures for apheresis (plasmapheresis, cytapheresis, and therapeutic apheresis), and (k) special considerations regarding transfusions in children under 4 months of age. Also discussed in the document are the following: (a) the review of agreements with users and with other institutions and centers; (b) corrective action plans or plans to prevent real or potential deficiencies; (c) quality assessments; (d) personnel training; (e) use of statistical methods, and (f) safety of donors, recipients, and personnel.
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